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    • Regulatory Affairs Manager - Mumbai - Astellas Pharma

    Astellas Pharma
    Astellas Pharma Mumbai

    1 month ago

    Default job background
    Description

    Job Description

    Astellas Pharma India seeks a Regulatory Affairs Manager, based in Mumbai, India.

    Purpose and Scope:

    • Plan, prepare, and submit market authorization, product registration, new indication, and maintenance of registration and compliance.
    • Interact and coordinate with DCGI (CDSCO), SFDA, and concerned regulatory bodies for necessary regulatory approval and licenses.
    • Provide back-up support to Pharmacovigilance.

    Responsibilities and Accountabilities:

    Regulatory Affairs

    • Support planning for market authorization of new products in India.
    • Prepare and compile regulatory dossiers for market authorization.
    • Prepare and submit dossiers for registration based on strategies of new product development plans.
    • Assess post-approval changes/variations and submit for necessary approval from the regulatory authority.
    • Coordinate with the Global RA team for assessing and implementing new regulations and compliance, and supporting RA projects.
    • Maintain registrations and licenses with timely planning and submission of renewal for business continuity.
    • Prepare and review artwork, product leaflets, API, and coordinate with labeling and packaging teams for timely execution and product launch.
    • Build associations and liaison with Indian health authorities (CDSCO), State FDA, CDTL, IPC, etc.
    • Close coordination with internal stakeholders (Medical Affairs, Marketing, Supply Chain, Commercial & Sales) to provide regulatory consultation and support in business.
    • Manage implementation, utilization, and compliance to RA systems (Veeva, EAGLE, GRACE, CCTA, BLUE, etc.).
    • Review PromoMat for regulatory and Code of Compliance, and consult with the Marketing team.
    • Provide back-up support to Pharmacovigilance.

    Management of Product Safety Information

    • Monitor the PV mailbox, 24/7 PV telephone, and other sources of product safety information (e.g., reported as part of Product Quality Complaints and Medical Information Enquiries).
    • Process safety information (Adverse Events) received from all sources by the Affiliate, in compliance with required timelines (reporting timelines), quality guidelines, and standards. Processing safety information includes the collection, translation, and forwarding to designated Regional Global PV Headquarters. If applicable: Timely ICRS submissions to the Competent Authority.
    • Use PV Case Tracking System, PV Register/LSIT/LSMV to capture Product Safety Information accurately.
    • Conduct local literature searches for Product Safety Information according to relevant procedures, if applicable.
    • Conduct and document follow-up of Product Safety Information as required per relevant procedures.

    Maintenance of PV System and Oversight Responsibilities

    • Provide input for the PSMF regarding affiliate communication to PV Regional Head Quarters.
    • Be aware of outsourced PV activities.
    • Ensure filing, storage, and archiving of PV documentation in accordance with PV regulations and Astellas policies and procedures.
    • Request access to, and be aware of, the affiliate business continuity plan (for example, system failure and other disasters) in relation to PV activities.
    • Be aware of all local studies and projects, including digital media and Astellas-sponsored websites that impact PV.
    • Ensure that communications from competent local authorities are forwarded to the Regional PV office - and work with the PV Regional HQ Office and Regulatory Affairs - to ensure appropriate responses are presented to competent local authorities, where applicable.

    Required Qualifications

    Knowledge:

    • Working knowledge on the regulatory environment of the Indian pharmaceutical industry.
    • Good knowledge of the Drugs and Cosmetics Act & Rules, India.
    • Good knowledge about regulations on new drug registration and clinical trials.
    • Good knowledge about Indian Regulatory guidelines and procedure.
    • Good English for communication with Global Colleagues.
    • University graduate and master majored in life science, medicine, pharmaceuticals.

    Experience:

    • Working experience in the pharmaceutical industry for a minimum of 5-8 years.
    • Experience in regulatory affairs, especially in registration of new drugs at least 5 years.
    • Experience in new product development.
    • Experience in preparation of dossiers for new chemical entities and new formulations.
    • Engaged in industry activities and experience in liaising with Indian Health Authorities.

    Working Environment

    • This position is based in Mumbai and will require on-site work. Maximum 1 day a week, work from home might be allowed.
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